PRIA Fee Category Table - Biopesticides Division - Amendments
|EPA No.||New CR No.||Action||Decision Review Time (Months) (1)||FY'22-FY'23 Fees ($)|
|B621||134||Amendment; Experimental Use Permit; no change to an established temporary tolerance or tolerance exemption.(3)||7||5,632|
|B622||135||Amendment; Experimental Use Permit; petition to amend an established or temporary tolerance or tolerance exemption.(3)||11||14,074|
|B641||136||Amendment of an established tolerance or tolerance exemption.||13||14,074|
|B680||137||Amendment; registered sources of active ingredient(s); no new use(s); no changes to an established tolerance or tolerance exemption. Requires data submission. (2) (3)||5||5,632|
|B681||138||Amendment; unregistered source of active ingredient(s). Requires data submission. (2) (3)||7||6,703|
|B683||139||Label amendment; requires review/update of previous risk assessment(s) without data submission (e.g., labeling changes to REI, PPE, PHI). (2) (3)||6||5,632|
|B684||140||Amending non-food animal product that includes submission of target animal safety data; previously registered (2) (3)||8||9,725|
|B685||141 (new)||Amendment; add a new biochemical unregistered source of active ingredient or a new microbial production site. Requires submission of analysis of samples data and source/production site-specific manufacturing process description.(3)||5||5,632|
1A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
2(a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
3Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.